Comparison of Phenylephrine Infusion With Colloids vs. Crystalloids for Reduction of Spinal-induced Hypotension During Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Incidence of Maternal Hypotension
研究概览
简要总结
The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.
详细描述
Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I and II
- •Elective cesarean section
- •Weight 50-120 kg, Height 150-180 cm
- •Normal singleton pregnancy
- •Beyond 36 weeks gestation
- •No known fetal abnormalities
- •Ages 18-35
排除标准
- •Contraindications to spinal anesthesia
- •Multiple gestation, placenta previa, accreta
- •Pregnancy induced hypertension or preeclampsia
- •Diabetes mellitus, cardiovascular diseases
- •Coagulopathy
- •Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction
- •Baseline HR <65
- •Failed spinal anesthesia/inadequate sensory block for surgery
- •History of abnormal bleeding
- •History of adverse reactions to hydroxyethylstarch
研究组 & 干预措施
colloid, then phenylephrine infusion
colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
干预措施: Colloid administration (Other)
colloid, then phenylephrine infusion
colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
干预措施: phenylephrine infusion (Drug)
crystalloid, then phenylephrine infusion
crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
干预措施: Crystalloid administration (Other)
crystalloid, then phenylephrine infusion
crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
干预措施: phenylephrine infusion (Drug)
结局指标
主要结局
Incidence of Maternal Hypotension
时间窗: participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby
次要结局
- Dosage of Phenylephrine Used(participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby)
- Incidence of Maternal Bradycardia(participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby)
- Fetal Cord Blood pH(delivery of the baby)
- APGAR Scores(Apgar scores were assessed at 1 amd 5 min after delivery of the baby)
- Incidence of Maternal Nausea and Vomiting(participants were assessed for an average of 20 min, after performing the spinal anesthetic till the delivery of the baby)
研究者
Sonia Vaida
M.D, Vice chair for research, Anesthesia Department
Penn State University